Category Archives: A.P. Pharma Inc. APPA

A.P. Pharma, Inc. (NASDAQ: APPA), a specialty pharmaceutical company, is committed to developing ethical (prescription) pharmaceuticals through the utilization of its proprietary polymer-based drug delivery systems. The Company’s main focus is on developing and commercializing its bioerodible injectable and implantable systems under the trade name Biochronomer™. For further information, visit the Company’s web site at www.appharma.com.

A.P. Pharma, Inc. (NASDAQ: APPA) is a specialty pharmaceutical company focused on the development and commercialization of innovative medical treatments utilizing their proprietary polymer-based drug delivery systems.

The company’s proprietary Biochronomer™ technology, featuring bioerodible polymers intended to create controlled-release pharmaceuticals that improve treatments for diseases or health-threatening conditions, is their primary focus as they continue to advance the technology. The company’s lead product candidate is APF530, which is currently in a pivotal Phase III clinical trial for the prevention of acute and delayed onset chemotherapy-induced nausea and vomiting, or CINV.

The company has made significant investments in the development of their bioerodible drug delivery technologies, which have produced tangible results. Specifically, A.P. Pharma has developed a broad family of polymers consisting of unique attributes referred to as poly (ortho esters), under the trade name Biochronomer. This technology has been designed for use in drug delivery applications with a number of technical advantages that include ease of manufacturing, flexible delivery times, various physical forms and multiple potential applications due to a neutral pH environment of acid sensitive actives (nucleic acids, proteins, etc.).

An advantage of Biochronomer technology is that it is extremely versatile, as products can be designed to deliver drugs at a variety of implantation sites such as under the skin, at the site of a surgical procedure, in joints, in the eye, or directly in muscle tissue. The company’s Biochronomer technology can provide sustained levels of drugs in systematic circulation for prolonged efficacy.

Having completed over 100 in vivo and in vitro studies, A.P. Pharma believes that their Biochronomer technology demonstrates that it can be used within a wide range of potentially applicable therapeutic areas including pain management, prevention of nausea and vomiting, control of inflammation and treatment of ophthalmic diseases. The company has also completed comprehensive animal and human toxicology studies that have established that their Biochronomer polymers are safe and well tolerated. Furthermore, the Biochronomer technology can be designed to deliver drugs over periods varying from days to several months.

A cancer diagnosis is devastating, and oftentimes the treatment following such diagnosis can be just as mentally and physically debilitating. The majority of patients receiving treatment experience some degree of emesis, or nausea and vomiting, associated with chemotherapy. The prevention and control of emesis is very important for the patient, and chemotherapy patients are typically administered an anti-emetic prior to treatment.

Specialty pharmaceutical company A.P. Pharma Inc. (Nasdaq: APPA) today announced positive results from its pivotal phase III study that compares the efficacy of the company’s lead product, APF530, with Aloxi for the prevention of emesis, also known as chemotherapy-induced nausea and vomiting (CINV).

The phase III trial is based on the participation of 1,395 patients, treated at 103 centers in the United States, Poland and India. The patients were classified according to their level of emetogenic chemotherapy to demonstrate the safety and efficacy of APF530.

According to the press release, A.P. Pharma’s APF530 was “generally well tolerated.” Regarding a side effect correlated with previous human use of granisetron (which is used in APF530), only one serious adverse event was reported as possibly attributed to APF530.

“We are highly encouraged with the results of our phase III trial and are working diligently to get our product approved for marketing as soon as possible. In the meantime, we will be carefully evaluating the best way to maximize the value of this asset for our shareholders,” Ronald Prentki, A.P. Pharma’s president and CEO stated in the press release.

From here, the company intends to create a data package appropriate for inclusion in its New Drug Application (NDA), which it plans on submitting to the U.S. Food and Drug Administration (FDA) during the fourth quarter of 2008.

“According to our market research, there are more than 6 million cycles of chemotherapy administered each year in the U.S. We believe this equates to an annual market opportunity in excess of $1 billion. Importantly, virtually all patients who experience acute onset nausea and vomiting will also experience delayed onset nausea and vomiting,” Prentki stated.

“There is currently only one 5HT3 antagonist, Aloxi, that addresses both acute and delayed segments. We are delighted to have the second product to potentially address this use. We believe that the positive results announced today from one of the largest randomized clinical trials ever conducted in CINV, together with physicians’ historical positive experience with our active ingredient, granisetron, will allow APF530 to play a major role in serving cancer patients,” he continued.